NCT00019643

Brief Summary

RATIONALE: Chemotherapy may affect various factors that can lead to weight gain. PURPOSE: Clinical trial to evaluate factors that may affect weight gain in women receiving adjuvant chemotherapy for stage I, stage II, or stage IIIA breast cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1999

Completed
7.6 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

October 31, 2023

Status Verified

March 1, 2012

First QC Date

March 2, 2007

Last Update Submit

October 27, 2023

Conditions

DepressionStage I Breast CancerStage IIIA Breast CancerNutritionStage II Breast CancerPsychosocial Effects/TreatmentQuality of Life

Keywords

adult solid tumorbody system/site cancerbreast cancercancercancer-related problem/conditiondepressiondepression and suicidenutritionpsychosocial effects/treatmentquality of lifesolid tumorstage I breast cancerstage I, II, and IIIA breast cancerstage II breast cancerstage III breast cancerstage IIIA breast cancerstage IIIB, IV, recurrent, and metastatic breast cancerstage, breast cancer

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically proven newly diagnosed stage I, II, or resectable IIIA primary breast cancer Scheduled to receive chemotherapy No distant metastases --Prior/Concurrent Therapy-- Biologic therapy: Not specified Chemotherapy: See Disease Characteristics No concurrent neoadjuvant chemotherapy Endocrine therapy: No concurrent thyroid medication Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics No prior oophorectomy Other: No concurrent alternative medicines alone No concurrent participation in dietary and/or exercise weight loss programs --Patient Characteristics-- Age: 18 to 80 Sex: Female Menopausal status: Premenopausal or postmenopausal Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No physical or mental disability that would preclude completing questionnaires No prior or concurrent diabetes mellitus No prior hypothyroidism or hyperthyroidism

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Cancer Prevention Studies Branch

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

DepressionBreast NeoplasmsNeoplasmsSuicideRecurrence

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSelf-Injurious BehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Noreen Aziz

    National Cancer Institute (NCI)

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

March 2, 2007

First Posted

March 6, 2007

Study Start

August 1, 1999

Study Completion

April 1, 2007

Last Updated

October 31, 2023

Record last verified: 2012-03

Locations

US(1)